Miro Samija

Senior Validation & CQV Lead · GMP Compliance & AI Governance

Fifteen years making GMP systems inspection-ready — now bringing the same rigour to AI.

Former Head of Validation at Pfizer Croatia. CQV lead for more than four years on Merck’s new Biotech Development Center in Switzerland, including a Swissmedic inspection with zero observations in the scope presented. ISO/IEC 42001 Lead Implementer.

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Vevey, Switzerland English · Français · Hrvatski
Portrait of Miro Samija
  • EU GMP
  • Annex 1
  • Annex 11
  • Annex 15
  • 21 CFR Part 11
  • GAMP 5
  • ALCOA+
  • ISO/IEC 42001
  • ISO/IEC 23894
  • ISO 9001
  • Valgenesis
  • LIMS
  • SDMS
  • MES
  • SAP
  • CARA
  • AutoCAD
  • Swissmedic
  • 15years
    in GMP pharmaceutical and biotech operations
  • 1,000+
    lab instruments under qualification documentation and risk assessment
  • 0obs.
    at a Swissmedic inspection, in the scope presented as lead presenter
  • 2,800m²
    GMP warehouse validated from design to release
  • ~2M vials
    in an automated −40 °C sample store, risk-assessed for full QC automation
  • 300–400
    GMP instruments and systems mapped into one site-wide data-interface map
01 / Competences

The full GMP lifecycle — from requirement to release, and beyond

Six areas of expertise, each backed by delivered work rather than training alone.

C-01

Qualification & validation

End-to-end CQV for equipment, utilities, facilities and laboratories.

  • CQV lifecycle
  • VMP
  • PCQP
  • DQ · IQ · OQ · PQ
  • FAT · SAT
  • Temperature mapping
  • Cold-chain & transport verification
  • Periodic review
  • Requalification
  • Equipment relocation
Proof pointValidation lead from design to release for a new 2,800 m² GMP warehouse at Pfizer Croatia.
C-02

Regulatory & data integrity

Computerized system qualification and data integrity testing aligned with EU and US expectations.

  • EU GMP
  • Annex 1
  • Annex 11
  • Annex 15
  • 21 CFR Part 11
  • GAMP 5
  • CSV
  • Data integrity testing
  • Access control
  • ALCOA+
Proof pointAuthored Valgenesis protocols for standalone computerized instruments, including data integrity and access-control tests.
C-03

Quality systems & inspections

Risk-based change management and an inspection-ready site, every day.

  • Change control
  • Deviations
  • CAPA
  • Risk assessment
  • Inspection readiness
  • Swissmedic
  • International audits
Proof pointZero critical or major validation observations across international audits and inspections as Head of Validation.
C-04

Systems & automation

Qualified systems, connected data flows and automated sample handling.

  • Valgenesis
  • CARA
  • LIMS
  • SDMS
  • MES
  • SAP
  • AutoCAD
  • AMRs
  • Automated sample storage
  • Isolators · RABS
  • HVAC
  • Backup power
Proof pointMapped instrument–SDMS–LIMS–MES and storage–EMS interfaces for 300–400 GMP systems into one site-wide map.
C-05

AI governance

Responsible AI management systems applied to regulated GMP work.

  • ISO/IEC 42001 AI management systems
  • AI system impact assessment
  • ISO/IEC 23894 AI risk management
  • AI-assisted GMP tools
Proof pointISO/IEC 42001 Lead Implementer and AI Controls Implementation (BSI); independent advisory on validation readiness for a vision-assisted quality workflow.
C-06

Leadership & delivery

Leading teams, coaching people new to GMP and keeping engineering, vendors and quality aligned.

  • Team leadership
  • Protocol-author supervision
  • Vendor & engineering interfaces
  • Inspection presenting
  • GMP training & coaching
  • Hiring panels
  • Client relationships
Proof pointLed a validation team of 5–6 at Pfizer; Swissmedic lead presenter at Merck, with the CQV team formally commended afterwards.
02 / Site coverage

Hands-on in every zone of a GMP site

From the warehouse to the QC lab to the data historian: the systems Miro has qualified, mapped or assessed first-hand.

STO-012–8 °C · −150 °C

Temperature-controlled storage

  • New 2,800 m² GMP warehouse, design to release
  • Controlled room-temperature and humidity-controlled zones
  • Four 2–8 °C cold rooms
  • Ultra-low freezers down to −150 °C
  • Temperature mapping and summer worst-case cold-chain transport verification
  • Power-failure and diesel-generator backup protocol
CLN-02Annex 1

Cleanrooms & isolators

  • Sampling laboratory with cleanroom and laminar flow hood
  • SKAN isolator suite
  • Isolators and RABS; airflow visualization (smoke) studies
PRC-03FAT → PQ

Process equipment & utilities

  • Filling equipment
  • Centrifuges
  • Autoclaves and parts washers
  • Washers and incubators
  • HVAC
  • Backup power
LAB-041,000+ instr.

QC & microbiology labs

  • Analytical, microbiology and temperature-controlled instruments
  • Decommissioning, transport and recommissioning from a legacy site
AUT-05−40 °C

Automated sample handling

  • Autonomous mobile robots serving every floor
  • Automated Hamilton sample store for ~2 million vials
  • Controls ensuring unique vial barcodes
DAT-06Part 11 · Annex 11

Data & computerized systems

  • Instrument → SDMS → LIMS → MES data flows
  • Storage units → EMS; autoclaves → data historian
  • QC user requirement specifications reviewed and revised
  • Calibration status and requalification tracking in SAP
QA-07QMS

Quality assurance

  • Change-control risk assessments
  • Deviations and CAPA
  • Inspection readiness
Dwg. PGMP-001 · Scope of hands-on experienceRev. 2026 · Not to scale
03 / PharmaGMP.ai

Sharing what works when AI meets GMP

Since October 2024, PharmaGMP.ai has been Miro’s independent, non-commercial platform for practical thinking on responsible AI in validation and quality documentation.

Non-commercial · Independent

AI in GMP, held to the same standard as everything else we validate.

Weekly LinkedIn writing on AI governance in GMP has led to direct advisory requests from technology developers and investors.

  • Free to read and shareNo products and no paywall — practical thinking shared openly with the industry.
  • Grounded in practiceViews formed from the regulations and from shop-floor qualification work.
  • Built for inspectors, tooIntended use, risk, human oversight and evidence that can be followed.
Read the weekly posts
Fig. 1 — Validation lifecycleGAMP 5 V-model
The validation V-model with AI governance across the lifecycle User requirements, functional specification and design specification descend to build and configure, then installation, operational and performance qualification ascend, each verifying its matching specification. AI governance under ISO/IEC 42001 spans the top; quality risk management and data integrity span the bottom. AI GOVERNANCE · ISO/IEC 42001 verifies verifies verifies URSRequirements FSFunctional spec DSDesign spec BUILDConfigure · FAT · SAT IQInstallation OQOperation PQPerformance QUALITY RISK MANAGEMENT · DATA INTEGRITY (ALCOA+)
The lifecycle doesn’t go away when a system learns. AI changes how we specify, verify and monitor — not whether we do.
Independent advisoryRegulated manufacturing

Validation readiness for vision-assisted quality workflows

Developed an end-to-end demonstration and due-diligence framework for a development-stage visual AI workflow, covering system boundaries, data integrity, human review, evidence, risk-based testing and future qualification planning.

Independent advisoryInvestors

EU GMP readiness for an acquisition

Outlined EU GMP requirements and the facility upgrades needed for a non-EU manufacturing site intended to supply the European market.

GroundworkOngoing

A 4.5 GB linked GMP knowledge base

Regulations, CQV and CSV linked in a structured knowledge database, plus a regulatory document search tool — the foundation for AI-assisted GMP work.

04 / Career

From engineering drawings to inspection rooms

An engineer first, with a background in electrical and instrumentation design for industrial projects — then fifteen years in GMP pharmaceutical and biotech operations.

A consistent thread: automating repetitive work, from database-driven engineering drawings to AI-assisted GMP tools.

EducationB.Sc. Mechanical Engineering, minor in Control Systems — Concordia University, Montreal
Based inVevey, Switzerland
  1. Oct 2024 — present

    Founder, Independent GMP & AI Governance Advisor

    PharmaGMP.ai · Vevey, Switzerland
    • Independent, non-commercial practice on responsible AI use in GMP, validation and quality documentation.
    • Weekly LinkedIn publications on AI governance in GMP, leading to direct advisory requests.
    • Independent advisory on validation readiness for a vision-assisted quality workflow and on EU GMP readiness for investors evaluating an acquisition.
  2. Mar 2021 — Sep 2025

    CQV Manager (external)

    Merck Biotech Development Center · Corsier-sur-Vevey, Switzerland

    Via Jacobs Engineering, Basel (2021–2022) and GXP Consulting Switzerland, Lausanne (2022–2025) — retained by the client through the change of employer, with contracts renewed several times.

    • Initiated and co-authored the Project Commissioning and Qualification Plan for GMP laboratories; directed qualification documentation and risk assessments for more than 1,000 instruments.
    • Swissmedic inspection: lead presenter for the laboratory-equipment PCQP and co-presenter for the autoclave and parts-washer PCQP — both with zero observations. Merck’s Global Analytical Department formally commended the CQV team.
    • Merck recognition award, with a colleague, for introducing more efficient commissioning protocols in Valgenesis.
    More from this roleShow less
    • Wrote the commissioning PCQP for GRP equipment and supported the PCQP for decommissioning, transport and recommissioning from the adjacent legacy site.
    • Authored Valgenesis qualification protocols for standalone computerized instruments, including data integrity and access-control tests; verified functions in the lab with analysts and executed selected protocols.
    • Reviewed and revised QC user requirement specifications; proactively mapped the data interfaces of 300–400 GMP instruments and systems into a single site-wide map used by QC.
    • Member of the four-person team that risk-assessed moving manual QC sample and material flows to full automation: AMRs on every floor and an automated −40 °C Hamilton store for about 2 million vials.
    • Oversaw FAT, SAT, DQ, IQ and OQ for critical laboratory systems; supervised protocol authors and managed interfaces between engineering, vendors and quality.
    • Designed and delivered inspection-readiness training and presentation coaching for QC and microbiology staff new to GMP; took part in candidate interviews alongside Merck staff.
    • As Solution Manager and Senior Consultant at GXP Consulting, top performer among the company’s Solution Managers in new clients, consultants placed and revenue — while acting as on-site lead at Merck.
  3. Apr 2017 — Mar 2021

    Owner & Director

    Astrotech d.o.o. · Zagreb, Croatia
    • Ran a consultancy delivering validation, automation and GMP documentation services.
    • Partnered with Valmer d.o.o. (Slovenia), a validation and calibration provider, presenting a joint offer to Croatian pharmaceutical manufacturers.
    • Won and delivered the validation lifecycle for autoclaves and process equipment at JGL, Rijeka, with client recognition for the work.
  4. Jun 2011 — Jan 2017

    QA Validation → Head of Validation

    Pfizer Croatia, formerly Hospira Zagreb · Zagreb, Croatia
    • Led a validation team of 5–6 covering routine validation, periodic qualification and periodic review across manufacturing, storage, laboratory and R&D as the site grew from about 80 employees.
    • Validation lead from design to release for a new 2,800 m² GMP warehouse; co-authored the PCQP and directed temperature mapping.
    • Zero critical or major validation observations across multiple international audits and inspections as Head of Validation.
    More from this roleShow less
    • Designed and executed a summer worst-case cold-chain transport verification between buildings (2–8 °C, multi-logger study) and a power-failure and diesel-generator backup protocol for GMP-critical storage.
    • Led FAT, SAT, IQ, OQ and PQ for process equipment and utilities, including filling equipment, centrifuges, autoclaves, washers and incubators; supported airflow visualization (smoke) studies.
    • Owned risk assessments for change controls, supported deviations and CAPA, and owned the requalification plan with calibration status tracking in SAP.
  5. Earlier

    Electrical & Instrumentation Design

    Industrial projects
    • Engineering foundation in electrical and instrumentation design, including database-driven engineering drawings in AutoCAD.
05 / Credentials

Certifications, training & languages

  • ISO/IEC 42001:2023 AI Management System Lead ImplementerBSI · Nov 2024Four-day course, exam passed
  • ISO/IEC 42001:2023 AI Controls ImplementationBSI · Mar 2026Exam passed
  • ISO 9001:2015 RequirementsExam passedQuality management systems
  • AI System Impact Assessment · ISO/IEC 23894:2023 AI Risk ManagementTrainingAssessing and managing risk across the AI system lifecycle
  • Quality Risk Management · Computerized Systems Validation · GAMP 5ECA AcademyGMP training
  • Building AIUniversity of HelsinkiFoundations of AI and machine learning
Education
B.Sc. Mechanical Engineering
Minor in Control Systems — Concordia University, Montreal, Canada
Languages
  • English Native
  • French Fluent
  • Croatian Fluent
06 / Contact

Let’s talk about GMP, validation — or AI that has to pass inspection.

Conversations are welcome — especially with teams bringing AI-enabled systems toward GMP use. Based in Vevey; working in English, French and Croatian.

Emailmsamija@pharmagmp.ai LinkedInMiro Samija